Effect of a functional bread on blood pressure, glucose metabolism and endothelial functio

Completed

• Conditions: Pre-hypertension; Circulatory System; Hypertension

• Registration Number: ISRCTN31436822
• Lead Sponsor: Europastry (Spain)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-20
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Patients (male and female) aged between 18 and 65 years with pre-hypertension but without antihypertensive medication

Exclusion Criteria

1. Severe hypertension (systolic blood pressure = 160 mmHg, diastolic blood pressure = 100 mmHg)
2. Type 2 diabetes
3. Body mass index (BMI) >35 kg/m^2
4. Target organ injuries attributed to hypertension
5. Inflammatory or infectious disease
6. Anti-inflammatory or antibiotic drugs
7. Alcoholism or drug abuse
8. Recent hypocaloric diet

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Daily mean blood pressure measured by a 24 hour continuous register at baseline and at the end of each intervention period (after one month).

Secondary Outcome Measures

Name	Time	Method
1. Blood pressure during activity and sleeping period<br>2. Blood pressure during the three hours after consuming the bread at morning. <br>3. Fasting glycemia, insulinemia and Homeostatic Measurement Assessment-Insulin Resistance (HOMA-IR) <br>4. Endothelial function and peripheral inflammation measured by biochemical markers. <br>5. Endothelial function measured by the Endo-PAT method<br>6. Adherence to the intervention<br>7. Tolerance and safety<br><br>Measured at baseline and at the end of each intervention period (after one month)